|Publication number||US5027813 A|
|Application number||US 07/487,918|
|Publication date||2 Jul 1991|
|Filing date||5 Mar 1990|
|Priority date||5 Mar 1990|
|Publication number||07487918, 487918, US 5027813 A, US 5027813A, US-A-5027813, US5027813 A, US5027813A|
|Inventors||Brian D. Pederson, John A. Hauck|
|Original Assignee||Cardiac Pacemakers, Inc.|
|Export Citation||BiBTeX, EndNote, RefMan|
|Patent Citations (5), Referenced by (31), Classifications (5), Legal Events (5)|
|External Links: USPTO, USPTO Assignment, Espacenet|
This invention relates broadly to the art of implantable medical devices and, more particularly, to a variable rate cardiac pacer apparatus, including an electrode interface sensor apparatus wherein the electrode interface sensor apparatus senses changes in impedance signals at the interface of the pacer housing and the patient's body tissues, wherein the changes are indicative of relative magnitude of physical activity and are processed and used as a control signal for the rate adaptive pacemaker.
The general activity level of a patient has been recognized in the art as useful for providing a programming signal for a variable rate cardiac pacer. For example, U.S. Pat. No. 4,140,132 suggests the use of a timing device having a self-generating voltage source to modify the constant rate of a cardiac pacemaker. That patent provides a device which embodies a cantilever suspended element which constitutes a high impedance voltage generator, such as a piezo-electric element which vibrates when subjected to motion, to provide alternating voltage from the resulting strain upon it. The cardiac pacer timing pulse rate is thereby varied as a rate of physical activity as measured by the piezo-electric element.
U.S. Pat. No. 4,428,378 suggests the use of an activity sensor mounted within a pacer. The activity sensor detects the general activity level of the patient and alters the escape interval of the pacer between a preset minimum and maximum in response to the detected activity level of the patient. U.S. Pat. No. 4,545,380 also suggests the use of a piezo-electric device for setting or adjusting parameters or functions of an implanted device such as a cardiac pacer in response to the user's impact near the implanted piezo-electric device. In yet another U.S. Pat. No. 4,771,780, it is suggested to use a motion sensor mounted within a rate responsive pacemaker. The motion sensor includes an enclosed housing having a conductive element therein that partially fills the space of a cavity within the enclosed housing. The conductive element is free to roll, flow or otherwise move around the inside of the housing in response to external forces. The types of sensors used in prior art devices are high in cost and present very complex design problems compared to the present invention.
The present invention has features and advantages not found in the prior art. This invention provides a variable rate cardiac pacer apparatus responsive to the physical activity of the patient including an electrode interface sensor apparatus which actually senses the physical movements of the pacemaker housing relative to its position in the body. The apparatus provides an impedance signal which can readily be processed into control signals for modifying the pacer pulse rates.
The present invention is directed to a variable rate cardiac pacer apparatus responsive to the physical activity of the patient wherein the pacer includes a metal housing. In one aspect of the invention, a first source of alternating current carrier signals of a first predetermined frequency in the range from about 500 to 10,000 Hertz is coupled to the pacer housing. A first sensing electrode having a sensing axis disposed primarily to sense movement in a first direction, is insulated from the pacer housing while in electrical contact with body tissues. The first sensing electrode is also coupled to the carrier signals wherein the first sensing electrode and the pacer housing are structured and arranged to operate as a first pair of interface sensing electrodes. A first sense amplifier means is coupled to the first pair of sensing electrodes for receiving and amplifying first modulated electrical signals developed across the sensing electrodes. A first demodulator circuit means for demodulating the first modulated carrier signal and recovering the first modulating signal therefrom is structured and arranged to receive the first amplified modulated carrier signal. The first modulating signal's frequency is proportional to the patient's rate of movement primarily in a first direction. A signal processing means receives the first demodulated signal and is structured and arranged to provide a processed control signal which is proportional to the demodulated signal. A rate control means receives the processed control signal, determines the rate at which the heart stimulating pulse will be generated in response to the processed control signal and provides a rate control signal to a pulse generator which is structured to provide stimulating pulses corresponding to the rate control signal.
In a further aspect of the invention, a second source of alternating current carrier signals of a second predetermined frequency in the range from 500 to 10,000 Hertz is also coupled to the pacer housing. Further, a second sensing electrode having a sensing axis arranged in a perpendicular relationship to the first sensing axis is structured and arranged to operate with the pacer housing to form a second pair of sensing electrodes wherein patient movement in a second direction is primarily sensed. Further yet, a second sense amplifier means is coupled to the second pair of sensing electrodes for receiving and amplifying a second set of modulated electrical signals developed across the second pair of sensing electrodes. The second set of amplified signals is presented to a second demodulator circuit for recovering a second modulating signal therefrom. The second modulating signal is further presented to the signal processing means for processing together with the first recovered modulating signals.
Other objects, features and advantages of the present invention will become apparent to those skilled in the art through the description of the preferred embodiment, claims and drawings herein wherein like numerals refer to like elements.
FIG. 1A schematically shows a pacer apparatus including an interface sensor electrode provided in accordance with the teachings of the invention.
FIG. 1B schematically shows a pacer apparatus having a pair of orthogonally positioned interface sensor electrodes as provided by the present invention.
FIG. 2 schematically shows a block diagram of the circuits employed in one aspect of the invention.
FIG. 3 shows a block diagram of the electronic circuits used in a further aspect of the invention.
FIG. 4 shows a modified circuit employing the interface sensors of the invention.
FIG. 5 shows a modified circuit employing the interface sensors of the invention shorted together.
FIG. 6 shows yet another aspect of the invention employing a multiplexing approach.
Referring now to FIG. 1A, a pacer apparatus 2 including a metallic housing or can 10, a top 11, and electronic circuit 100A is shown. The pacer apparatus 2 is implanted in a patient and an electrode 12A is located proximate the pacer apparatus, but insulated from the metallic housing 10 so as to sense impedance changes in the interface area generally indicated as 60 where the pacer apparatus interfaces with the patient's body tissues. In one embodiment of the invention, the top 11 is made of an insulating material such as plastic and the interface electrode 12A is embedded in the top.
Referring now to FIG. 2, a more detailed block diagram illustrating the elements of electronic circuit 100A is shown. It will be understood that other conventional circuitry is included within the rate adaptive pacer 2, however only those elements essential to the invention have been specifically shown in the drawings so as to highlight the teachings of the present invention. Electronic circuit 100A comprises a first sense amplifier 14A having first and second inputs across which is located a first source of alternating current carrier signals 22A wherein the first current carrier signals have a first predetermined frequency. The first sensing electrode 12A is coupled by means of conductor 32 to the alternating current source 22A and by means of conductor 33 connected to conductor 32 to a first input of amplifier 14A. The second input of amplifier 14A is coupled at conductor 35 to the other side of the current source 22A and by conductor 38 to the metal housing 10 of the pacer, a portion of which is shown in FIG. 2. The output of amplifier means 14A is coupled by conductor 16 to demodulator circuit means 17 which is further coupled to signal processor means 18. Rate control means 56 is coupled to signal processor means 18 by line 20. Rate control means 56 provides a control signal via conductor 57 to pulse generator means 71. The pulse generator means 71 outputs a stimulating pulse.
Referring now to FIG. 1B an alternative embodiment of the invention is shown having at least two interface sensing electrodes 12A and 12B. 12A and 12B are structured and arranged to sense motion primarily along intersecting sensing axes and, advantageously are disposed to have their sensing axes in perpendicular relationship to each other. The small graph beside the pacer apparatus 2 indicates the standard cartesian coordinate system having X, Y and Z axes. In the example shown, the sensing electrode 12A may be disposed to sense movement primarily in the direction along the Z axis while the second sensing electrode 12B may be disposed to sense movement of the patient along the Y axis. At any given time these movements may be summed to yield a movement vector. The pacer apparatus 2, in this case, has additional circuitry to provide current sense signals from the second sensing electrode in electronic circuit 100B.
Referring now to FIG. 3, a more detailed diagram of the elements of circuit 100B is shown. The circuit is substantially similar to circuit 100A with the addition of another set of motion sensing components associated with the second interface sensing electrode. These additional components are, namely, sense amplifier means 14B, a second source of a carrier signal 22B and an additional demodulator 17B. Conductors 40, 42 and 44 couple the second electrode 12B to the second current source and second sense amplifier means. The connections of the components also found in circuit 100A are as described above. The output of sense amplifier 14B is provided to the second demodulator 17B by conductor 15 and the demodulated signals from 17A and 17B are then processed, as explained below, by the signal processor means 18, to present a processed signal proportional to the motion of the patient in two directions to the rate control means. Note that in this embodiment current carrier sources 22A and 22B preferably operate at different carrier frequencies.
Referring now to FIG. 4, a detailed diagram of an alternative embodiment of circuit 100B is shown. The circuit in FIG. 4 utilizes sensing electrodes 12A and 12B together as a single pair of sensing electrodes coupled to first and second inputs of amplifier means 14A. In this configuration, the can is not coupled to the amplifier means and the need for a second amplifier means is eliminated. The operation is similar to the configuration of 100A wherein the second sensing electrode is used instead of the pacer can 10.
Referring now to FIG. 5, yet another alternative embodiment of circuit 100B is shown in detail. In FIG. 5, interface sensing electrodes 12A and 12B are shorted together by conductor 13. In this way, changes in impedance signals which ocCur in first and second directions along the first and second sensing axes are simultaneously sensed by the pair of shorted interface electrodes and are carried on the same line to a first input of amplifier means 14A. The second input of amplifier 14A is connected via conductors 35 and 38 to the can 10. Downstream operation of the circuit of FIG. 5 is similar to that described with respect to circuits 100A and 100B hereinabove.
Referring now to FIG. 6, yet another alternative embodiment of circuit 100B is shown employing a multiplexing approach. In FIG. 6, two interface sensing electrodes 12A and 12B are disposed on the pacemaker in a manner consistent with that shown in FIG. 1B. A single amplifying means 14A is connected to the common pole C of switch SW. Switch SW is preferably a solid state switching device which is switched via a switch control, such as a clock, which is not shown. Electrode 12A is connected by conductor 32A to a first pole A of the switch SW and the second interface electrode 12B is connected by connector 32B to a second pole B of switch SW. In operation, switch SW alternates switching the first input of amplifier means 14A through conductor 33 from pole A to pole B. Therefore, the signal introduced into the demodulator 17 is a signal which alternates between sensing movement in a first direction and sensing movement in a second direction. Such information can then be processed serially by the signal processor to provide a control current, proportional to the patient's movement, to the rate control means 56.
Having described the arrangement of the elements of the invention in considerable detail, it will prove beneficial to the understanding of the invention to now describe the operation of the invention. Referring now primarily to FIG. 3 with continuing reference to FIG. 2, note that the first and second interface sensing electrodes 12A and 12B each operate to form a first and second pair of sensing electrodes when each is individually paired with the metallic housing 10 of the pacer apparatus. As the patient moves, the amount and rate of movement will cause changes in high density current areas which immediately surround the first and second interface sensing electrodes. These high density current areas are generally indicated as areas 60 and 62 (shown in FIG. 1B). The impedance changes are carried as modulated signals to the first and second sense amplifiers 14A and 14B. The first and second sense amplifiers are coupled to the first and second pair of sensing electrodes respectively. The amplifier means receive and amplify the first and second modulated electrical signals developed across the sensing electrodes. These amplified modulated signals are then presented to the first and second demodulators 17A and 17B which demodulate the odulated carrier signals and recover the first and second modulating signals therefrom. The modulating signals are proportional to the impedance field around the first and second sensing electrodes which, in turn, are proportional to the patient's amount and rate of movement as is sensed in primarily a first direction by electrode 12A and primarily a second direction by electrode 12B.
The demodulated signals are then received by a signal processor means 18 which operates by conventional signal processing means to provide a processed signal proportional to the sensed movement via conductor 20 to the rate control means 56. Signal processing may be done using well known methods such as automatic gain control, peak detection and signal averaging techniques. The processed signal is then received by the rate control means 56 which responds to the processed signal by modifying the parameters controlling stimulating pulse rate, including attack and decay parameters, in a manner consistent with the movement exhibited by the patient as measured by the interface sensing electrodes. The rate control means provides a rate control signal so as to adjust the rate at which the pacer apparatus outputs stimulating pulses in a manner consistent with patient movement. The rate control means 56 provides the rate control signal to the pulse generator 71 which outputs pulses at a rate as determined by the rate control means. As those skilled in the art will appreciate, the circuitry of 100A operates in substantially the same manner except that only one interface signal from the first sensing electrode 12A is used.
It is believed that better overall sensing of the patient's movement can be accomplished using two or more interface sensing electrodes arranged in an orthogonal relationship. Although examples have been shown herein using one and two interface sensing electrodes, it may be possible, and in some cases even desirable, to have additional interface sensing electrodes with corresponding motion sensing circuitry included in the pacer apparatus. It will be understood by those skilled in the art that the motion sensing apparatus as provided by the present invention may operate in combination with a conventional pacemaker and also in combination with other rate adaptive techniques to provide a rate adaptive pacer apparatus which is responsive to the physicial activity of the patient.
This invention has been described herein in considerable detail in order to comply with the Patent Statutes and to provide those skilled in the art with the information needed to apply the novel principles and to construct and use such specialized components as are required. However, it is to be understood that the invention can be carried out by specifically different equipment and devices, and that various modifications, both as to the equipment details and operating procedures, can be accomplished without departing from the scope of the invention itself.
|Cited Patent||Filing date||Publication date||Applicant||Title|
|US4310000 *||23 Jan 1980||12 Jan 1982||Medtronic, Inc.||Implantable pulse generator having separate passive sensing reference electrode|
|US4722342 *||16 Jun 1986||2 Feb 1988||Siemens Aktiengesellschaft||Cardiac pacer for pacing a human heart and pacing method|
|US4823797 *||15 Jun 1987||25 Apr 1989||Siemens Aktiengesellschaft||Apparatus and method for impedance measurement of body tissues|
|US4846195 *||18 Mar 1988||11 Jul 1989||Intermedics, Inc.||Implantable position and motion sensor|
|US4907593 *||21 May 1987||13 Mar 1990||Biocontrol Technology, Inc.||Adaptation of heart pacing to physical activity|
|Citing Patent||Filing date||Publication date||Applicant||Title|
|US5179947 *||15 Jan 1991||19 Jan 1993||Cardiac Pacemakers, Inc.||Acceleration-sensitive cardiac pacemaker and method of operation|
|US5282840 *||26 Mar 1992||1 Feb 1994||Medtronic, Inc.||Multiple frequency impedance measurement system|
|US5423871 *||7 Jan 1994||13 Jun 1995||Pacesetter Ab||Method and device for monitoring electrodes of electrical heart stimulators|
|US6076015 *||27 Feb 1998||13 Jun 2000||Cardiac Pacemakers, Inc.||Rate adaptive cardiac rhythm management device using transthoracic impedance|
|US6152954 *||22 Jul 1998||28 Nov 2000||Cardiac Pacemakers, Inc.||Single pass lead having retractable, actively attached electrode for pacing and sensing|
|US6161042 *||21 May 1999||12 Dec 2000||Cardiac Pacemakers, Inc.||Rate adaptive cardiac rhythm management device using transthoracic impedance|
|US6208900 *||28 Mar 1996||27 Mar 2001||Medtronic, Inc.||Method and apparatus for rate-responsive cardiac pacing using header mounted pressure wave transducer|
|US6345204||14 Sep 2000||5 Feb 2002||Cardiac Pacemakers, Inc.||Single pass lead having retractable, actively attached electrode for pacing and sensing|
|US6463326||20 Jan 2000||8 Oct 2002||Cardiac Pacemakers, Inc.||Rate adaptive cardiac rhythm management device using transthoracic impedance|
|US7062326||6 Feb 2003||13 Jun 2006||Cardiac Pacemakers, Inc.||Method and apparatuses for monitoring hemodynamic activities using an intracardiac impedance-derived parameter|
|US7092757||12 Jul 2002||15 Aug 2006||Cardiac Pacemakers, Inc.||Minute ventilation sensor with dynamically adjusted excitation current|
|US7101339||13 Dec 2002||5 Sep 2006||Cardiac Pacemakers, Inc.||Respiration signal measurement apparatus, systems, and methods|
|US7774934||8 Dec 2005||17 Aug 2010||Cardiac Pacemakers, Inc.||Method for making a terminal connector|
|US7885707||15 Sep 2005||8 Feb 2011||St. Jude Medical, Atrial Fibrillation Division, Inc.||Method of scaling navigation signals to account for impedance drift in tissue|
|US8050764||29 Oct 2003||1 Nov 2011||Cardiac Pacemakers, Inc.||Cross-checking of transthoracic impedance and acceleration signals|
|US8209011||17 Sep 2007||26 Jun 2012||Cardiac Pacemakers, Inc.||Automatically configurable minute ventilation sensor|
|US8209035||23 Jun 2008||26 Jun 2012||Cardiac Pacemakers, Inc.||Extendable and retractable lead having a snap-fit terminal connector|
|US8285398||7 Jul 2010||9 Oct 2012||Cardiac Pacemakers, Inc.||Lead with terminal connector assembly|
|US8306621||16 Feb 2007||6 Nov 2012||Cardiac Pacemakers, Inc.||Cardiac cycle synchronized sampling of impedance signal|
|US8423142||31 Oct 2011||16 Apr 2013||Cardiac Pacemakers, Inc.||Cross-checking of transthoracic impedance and acceleration signals|
|US8442633||30 Oct 2012||14 May 2013||Cardiac Pacemakers, Inc.||Cardiac cycle synchronized sampling of impedance signal|
|US8594785 *||1 Feb 2008||26 Nov 2013||Boston Scientific Neuromodulation Corporation||Neurostimulation system and method for measuring patient activity|
|US8688214||10 May 2013||1 Apr 2014||Cardiac Pacemakers. Inc.||Cardiac cycle synchronized sampling of impedance signal|
|US8744565||30 Apr 2008||3 Jun 2014||Medtronic, Inc.||Multi-frequency impedance monitoring system|
|US8805490||7 Jan 2011||12 Aug 2014||St. Jude Medical, Atrial Fibrillation Division, Inc.||Method of scaling navigation signals to account for impedance drift in tissue|
|US8880171||13 Feb 2014||4 Nov 2014||Cardiac Pacemakers, Inc.||Cardiac cycle synchronized sampling of impedance signal|
|US20030105499 *||8 Oct 2002||5 Jun 2003||Cardiac Pacemakers, Inc.||Rate adaptive cardiac rhythm management device using transthoracic impedance|
|US20070060833 *||15 Sep 2005||15 Mar 2007||Hauck John A||Method of scaling navigation signals to account for impedance drift in tissue|
|EP0555988A2 *||3 Feb 1993||18 Aug 1993||Telectronics N.V.||Minute volume rate-responsive packmaker employing impedance sensing on a unipolar lead|
|EP0665032A2 *||5 Oct 1994||2 Aug 1995||Cardiac Pacemakers, Inc.||Using sub-threshold unipolar pacing markers to improve the interpretation of surface EKG in pacemaker patient|
|WO2008095185A1 *||1 Feb 2008||7 Aug 2008||Boston Scient Neuromodulation||Neurostimulation system for measuring patient activity|
|U.S. Classification||607/19, 600/547|
|5 Mar 1990||AS||Assignment|
Owner name: CARDIAC PACEMAKERS, INC., MINNESOTA
Free format text: ASSIGNMENT OF ASSIGNORS INTEREST.;ASSIGNORS:PEDERSON, BRIAN D.;HAUCK, JOHN A.;REEL/FRAME:005246/0608
Effective date: 19900212
|1 Dec 1992||CC||Certificate of correction|
|13 Sep 1994||FPAY||Fee payment|
Year of fee payment: 4
|13 Oct 1998||FPAY||Fee payment|
Year of fee payment: 8
|5 Dec 2002||FPAY||Fee payment|
Year of fee payment: 12